USP <232> Elemental Impurities — Limits
Issued by United States Pharmacopeia (USP)
StandardAudit Scope
Sets permitted daily exposure (PDE) limits for elemental impurities (arsenic, cadmium, lead, mercury, and additional Class 2A/2B/3 elements) in pharmaceutical and dietary supplement products.
What It Proves
A product or ingredient manufacturer has tested against USP-specified elemental-impurity limits and met the published PDE thresholds for the dose form and route of administration in question.
What It Does Not Prove
USP <232> is a STANDARD, not a certification. There is no USP-issued <232> certificate. Vendor claims of '<232> compliant' are self-declarations unless paired with a third-party laboratory result (ISO/IEC 17025 accredited) showing test methodology (USP <233>) and quantitative results below PDE thresholds. Self-declaration alone is unverifiable.
How Vendors Report It
You may see this listed as:
Related Glossary Concepts
Evaluating Manufacturer Credentials?
Our directory shows certification status, verification details, and assessment rationale for every listed vendor.